In-Vitro Diagnostics, Inc Dba Serolab

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted January 24, 2025, found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of manufacturer instructions, calibration records, and interview with laboratory personnel, the laboratory failed to perform calibration verification activities for quantitative Immunoglobulin E (IgE) measurements for two of two six-month periods in 2024. The findings included: 1. Based on review of the Immulite 2000 /2500 operator's manual, under Adjusting an Assay, stated the following: "Before using a new kit lot, an adjustment must be run. This initial adjustment corrects for any Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- variations in performance between your Instrument and the manufacturer's Instrument. In addition, kits must be readjusted periodically. The adjustment schedule for a kit is indicated in the kits package insert. The reagent status and bead status windows indicate if an adjustment is due." 2. Based on review of the calibration records, the IgE assay has a two-point calibration called an "adjustment", where two levels of calibrators are run in four replicates, with a Low Adjustor and a High Adjustor. 3. In an interview at 12:43 hours on 1/24/2025 in the laboratory, the Laboratory Manager stated the laboratory had not run any calibration verification procedures on the IgE quantitative assay. D5783

Summary Statement of Deficiencies D0000 An onsite survey conducted February 9, 2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the manufacturer instructions for use, laboratory policy, and interview with facility personnel, the laboratory failed to establish ambient temperature specimen stability and the effect on overall specimen integrity of multiple freeze-thaw cycles for two of two assays in use since November 2022. The findings included: 1. Based on review of the IMMULITE 2000 Total IGE assay instructions for use, (revision IMMULITE 2000 Total lgE (PIL2KIE-24, 2018-08-24)), the instructions stated the following: "Blood collection tubes from different manufacturers may yield differing values, depending on materials and additives, including gel or physical barriers, clot activators and/or anticoagulants. IMMULITE 2000 Total lgE has not been tested with all possible variations of tube types. Volume Required: 5 L serum Storage: 3 days at 2-8 C, or 6 months at -20 C Based on review of the IMMULITE 2000 3gAllergy Specific lgE Universal Kit (revision IMMULITE 2000 3gAllergy Specific lgE Universal Kit (PIL2KUND-34, 2022-08)), the instructions stated the following: Specimen Collection Blood collection tubes from different manufacturers may yield differing values, depending on materials and additives, including gel or physical barriers, clot activators. Specific lgE has not been tested with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- all possible variations of tube types. Volume Required: 50 L serum Storage: 7 days at 2-8C, or 6 months at -20 C" The manufacturer did not provide an ambient temperature specimen stability in the instructions for use. The manufacturer provided a frozen temperature stability at -20C, but did not make any mention of the effect of multiple free/thaw cycles. 2. Based on review of the laboratory policy "Specimen Processing", approved by the laboratory director on 11/11/2022, the policy stated the following: "Specimen collection* Blood may be collected in red top tubes, SST tubes, or tiger top tubes in order to provide serum for testing. After collection, the blood is allowed to stand at room temperature for 30 minutes then centrifuged to separate serum and cells. After centrifugation, the serum is poured into a plastic screw-cap vial provided by Serolab. It is important that the blood/serum not be stored or shipped in glass vials as covalent binding of antibodies with glass can occur. If a centrifuge is not available, the blood is placed upright in a refrigerator overnight, allowing the clot to retract; the serum is then carefully decanted into the plastic vial provided, taking care not to pour off cells with the serum. *Serolab does not collect specimens; they are collected at the clinic/lab that orders the testing. Specimen labeling Serum specimens should be labeled at the ordering facility with the patient's name, date of birth, physician's name, and date specimen was drawn. Specimen storage The specimen should be stored at- 20C until shipping/mailing. The specimen does not require refrigeration during shipment but is stored under refrigeration 2-8C up to 3 days, while testing is in progress. Once all initial testing is complete, any remaining specimens are stored -20 C for approximately six months in the event additional tests might be ordered." 3. In an interview at 15:49 hours on 2/9/2023 in the front office space, the laboratory manager stated specimens were collected in tiger top blood collection tubes provided by the laboratory, specimens were then either frozen at the collection site or refrigerated at the collection site and then mailed to the laboratory at ambient temperature. Once the specimens arrived in the laboratory, they were frozen at -20C until they could be analyzed. When asked if the laboratory had evaluated or established an ambient temperature stability for specimen integrity, she stated the laboratory had not. When asked if the laboratory had evaluated the effect of repeat freeze/thaw cycles on specimen integrity, the laboratory manager stated they had not performed any specimen stability studies to establish ambient temperature stability or free/thaw cycle stability. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a routine recertification survey conducted on April 28, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6108 - 42 C.F.R. 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor; D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with facility personnel, the laboratory failed to include 2 of 3 testing personnel in performing proficiency testing for 6 of 6 events between 2019 and 2020. The findings included: 1. Based on review of the analytic records for 6 of 6 College of American Pathologist proficiency testing challenges for IgE, 6 of 6 events were performed by Testing Personnel 3 (as listed on the CMS-209 Laboratory Personnel Report). 2. In an interview at 11:17 hours on 4/28/2021 in the front room, the laboratory supervisor stated that Testing Person 3 had "set up" the last six College of American Pathologist proficiency testing challenges. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy, accuracy assessment records, and interview with facility personnel, the laboratory failed to assess the accuracy twice annually for the IgG allergen specific testing in 2019 and 2020. The findings included: 1. Based on review of the facility policy "Internal Proficiency Testing Plan IgG", the policy stated the following: "1. Internal proficiency testing will be set up three times per year. 2. Pull five patients' sera that have been previously tested and have been shown to have both positive and negative test results for various specific IgG's. Volume for these 5 sera must total 5 mls. 3. Pool sera together in the same container for testing. 4. Samples will be split into two separate tubes and labeled with test patient accession number and date. One sample will be sent to Hycor Biomedical for comparison testing." 2. Based on review of accuracy assessment records, the laboratory performed the accuracy assessments one time in 2019 on 12/04/2019 and one time in 2020 on 11 /24/2020. 3. In an interview at 10:40 hours on 4/28/2021, the surveyor requested documentation of a second assessment in both 2019 and 2020 and the laboratory supervisor stated the laboratory did not have documentation of a second assessment for 2019 and 2020. Key: Mls - milliliters IgG - Immunoglobulin G D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observations, review of temperature records, and interview with facility personnel, the laboratory failed to ensure the temperature of a laboratory refrigerator was within limits for storage of reagents and specimens for 181 of 181 days temperatures were recorded that were reviewed between August 2020 and April 2021. The findings included: 1. Based on surveyor observations at 13:58 hours on 4/28 /2021 in the laboratory, the refrigerator labeled "REF SAMS" was at 10 degrees Celsius. The following items were stored in the refrigerator: 1 bottle of Hytec Probe Cleaning Solution - Reference 288197 - Storage requirements 2 to 8 degrees Celsius. 3 bottles of Hytec IgE diluent - Reference 309046 - Storage requirements 2 to 8 degrees Celsius. 1 box of Specific IgE calibrator set - Reference 74119 - Storage requirements 2 to 8 degrees Celsius. 17 bottles of Hytec Substrate Diluent - Reference 308050 - Storage requirements 2 to 8 degrees Celsius. 2. Based on an interview at 13: 58 hours on 4/28/2021, the following 13 specimens had been stored in the REF SAMS refrigerator prior to their analysis on 4/28/21: 211170001S, 21170003S, 21117004S, 21117005S, 21117006S, 21117007S, 21117008S, 2117009S, 211170010S, 211170011S, 211170012S, 211170013S, 21117014S. Based on review of the Hycor instructions for use, under SPECIMEN COLLECTION AND HANDLING, the instructions state: "Only serum has been validated for this procedure. Obtain patient sample by non-traumatic venipuncture using a red-topped or serum separator vacuum tube. Allow the samples to clot at room temperature for at least 20 to 30 minutes, until the clot just begins to retract. Spin the serum in a centrifuge. Following centrifugation -- 2 of 8 -- transfer the serum to a 12x75mm tube. Cap the specimens and refer to the stability summary below for storage limitations. Refrigerated (2 to 8 degrees C): 21 days Frozen (less than or equal to -20 degrees C) : 6 months Transport Temperature: Ambient or cold packs" 3. Based on review of the laboratory temperature records, the refrigerator REF SAMS had not achieved acceptable temperatures between 2 and 8 degrees Celsius for 181 of the last 181 recorded measurements. In April 2021, 20 of 20 temperatures measurements were outside of acceptable ranges. In March 2021, 23 of 23 temperatures measurements were outside of acceptable ranges. In February 14 of 14 temperatures measurements were outside of acceptable ranges. In January 2021, 20 of 20 temperatures measurements were outside of acceptable ranges. In December 2020, 21 of 21 temperatures measurements were outside of acceptable ranges. In November of 2020, 19 of 19 temperatures measurements were outside of acceptable ranges. In October of 2020, 22 of 22 temperatures measurements were outside of acceptable ranges. In September of 2020, 21 of 21 temperatures measurements were outside of acceptable ranges. In August of 2020, 21 of 21 temperatures measurements were outside of acceptable ranges. The last acceptable temperature was recorded as 4 degrees Celsius on July 31, 2020. 4. In an interview at 14:10 hours on 4/28/2021 in the front room, the laboratory supervisor stated confirmed there had been an event in July 2020 and the refrigerator had not been as cold since the event. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the Hycor Hytec 288 operator's manual, laboratory maintenance records, and interview with facility personnel, the laboratory failed to perform and document daily maintenance for 7 of 7 weeks between 3/8/21 and 4/26/21. The findings included: 1. Based on review of the Hycor Hytec 288 operator's manual, on page 86 under Maintenance, the manual stated: "All maintenance procedures must be performed with the frequency described, other the proper operation of the HYTEC 288 is not guaranteed. The frequent is indicated by characters meaning daily (D), weekly (W), monthly (M), half yearly (1/2Y) or yearly (Y). " The chart included the following daily maintenance tasks: Empty the waste bottle Make a backup of the database files Rinse the substrate bottle with DI water and let dry 2. Based on review of the maintenance documentation, the "Report: Maintenance Log Report" did not contain documentation of daily maintenance tasks (empty the waste bottle, making a backup of the database files, or rinse the substrate bottle with DI water) between 3/8 /21 and 4/26/21. 3. Based on review of the file pathway Hycor (C:) BackupDB on instrument number 1, Database backups were performed on the following dates: 3/8 /21, 3/15/21, 3/23/21, 3/29/21, 4/5/21, 4/9/21, 4/13/21, 4/19/21, 4/24/21, 4/26/21. In an interview at 13:40 hours on 4/28/2021 in the laboratory, the laboratory supervisor stated the database backups were automatically performed whenever staff would log out and log back into the instrument software. The laboratory supervisor also stated that the files were automatically backed up to a separate server through a laboratory router. When the surveyor requested the laboratory, supervisor verify the instrument was backed up to the separate server on a daily maintenance, the laboratory supervisor stated that the laboratory would need additional information technology support to confirm the extra server back-up. 4. In an interview at 13:45 hours on 4/28/2021 in the -- 3 of 8 -- front room, when the surveyor requested documentation of performing daily maintenance tasks between 3/8/21 and 4/26/21 for Instrument number 1, the laboratory supervisor stated the laboratory performed many of the daily maintenance tasks but did not keep separate documentation of the performance of these tasks. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, the CMS Form 209 Laboratory Personnel Report, review of the laboratory's personnel records, and interview with facility personnel, the Laboratory Director failed to delegate competency assessments to an individual who qualified as a Technical Consultant under 493.1409 for competency assessments of 3 of 3 testing personnel performing moderate complexity testing in 2019 and 2020. The findings included: 1.Based on a review of the laboratory's policy "Delegation of Authority", the document states: "Acting in my capacity of Laboratory Director, Clinical Consultant, and Technical Supervisor for Serolab, I hereby deleted the following responsibilities to my Supervisor: 5. Annually evaluating and documenting the performance competency of all testing personnel." This document was signed by the Laboratory Director on 1/13 /2017. 2. Based on review of the laboratory's procedure "Laboratory Staff Orientation, Training and Assessment", approved for use by the laboratory director on 3/28/2013, the procedure states: "ANNUAL EVALUTION AND COMPETENCY OF STAFF Each employee will be evaluated for competency at six months from hire and annually thereafter. The Laboratory Director, General Supervisor, or Technical Consultant will visually examine and review each employee's understanding and performance in each area of responsibility. This review will include the pre-analytical (order, collection and handling of specimen, requisition and processing), analytical (actual performance of the test, including maintenance and quality control) and postanalytical (review of results, documentation and release of results to patient record) phases of testing. Additional competency may be evaluated by review of proficiency testing records: by showing acceptable performance, documentation, review, and

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control instructions for use, laboratory policies and procedures, quality control records, and interview with facility personnel, the laboratory failed to accurately establish acceptability for two of two lots of controls reviewed between 2017 and 2018. The findings included: 1. Based on review of the Hycor Specific and Total IgE Controls (Ref 71207), the instructions for use states the following under EXPECTED VALUES: "The control ranges listed have been established by Hycor Biomedical. Because of differences in reagent lots and individual laboratory equipment, it is recommended that these values be used as guidelines to aid in establishing a range with accurately reflects user performance." 2. Based on review of the laboratory's procedure titled "Technical Procedure for Total IgE Testing EIA", approved by the laboratory director on 1/9/17, under QUALITY CONTROL, states the following: "Mean values with acceptable ranges are established internally and are used to monitor assay performance. The Levy-Jennings graphs, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- available within each of the 4 Hytec 288 analyzers, will be printed on a monthly basis and reviewed for shifts and trends, accuracy, and precision. Ranges for each new lot of liquid controls are generally determined by calculating the mean and standard deviation from 20 replicate runs performed over at least 3 days if possible. The target is set at plus or minus two standard deviations from the mean unless specifically stated otherwise within the assays procedure. The new lab mean must fall within the manufacturer's stated range to be valid." 3. Based on review of the quality control records, the ranges established for Lot 154102 included a value of 172.24, which is outside the guidelines for lot 154102 (339 - 903) and the laboratory calculated a plus or minus 1 standard deviation acceptable range. This lot was in use on 6/23/2017. The range established by the laboratory was 462.5 - 670. Based on review of quality control bar graphs for instrument 1, the laboratory obtained a value of 451.05 on 7/13 /2017, below the 462.5 - 670 established by the lab. There are no repeats for quality control on 7/13/2017 for Instrument 1. Based on review of quality control bar graphs for instrument 4, the laboratory obtained a value of 690.64 on 7/14/2017, above the 462.5 - 670 established by the lab. There are no repeats for quality control on 7/14 /2017 for Instrument 4. 4. Based on review of the quality control records, the ranges established for Lot 156484 included a value of 11.06, which is outside the guidelines for lot 156484 (265-806) and the laboratory calculated a plus or minus 1 standard deviation acceptable range. This lot was in use on 12/03/2018. The range established by the laboratory was 462.35 - 748.89. Based on review of quality control bar graphs for instrument 4, the laboratory obtained a value of 779.89 on 12/11/2018, above the 462.35 - 748.89 established by the lab. There are no repeats for quality control on 12 /11/2018 for Instrument 4. Based on review of quality control bar graphs for instrument 4, the laboratory obtained a value of 350.97 on 12/13/2018, below the 462.35 - 748.89 established by the lab. There are no repeats for quality control on 12 /13/2018 for Instrument 4. Based on review of quality control records, the laboratory was not printing Levy-Jennings graphs as required by established laboratory policy. The laboratory was printing bar graphs. Additionally, the laboratory was not entering the established limits into the quality control program. Using the bar graph methodology, the laboratory is not able to accurately distinguish values between the mean, and plus or minus 1, 2, or 3 standard deviations away from the mean. 4. In an interview at 14:00 hours on 1/8/2015 in the laboratory, the Laboratory Manager stated the laboratory had been unaware the outlying values were included in the acceptability range establishment or that the laboratory had established a plus or minus one standard deviation acceptability range instead of a plus or minus two standard deviation range as required by the laboratory policy. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of quality control instructions for use, laboratory policies and procedures, quality control records, and interview with facility personnel, the Technical Consultant failed to ensure the laboratory established the parameters for acceptable levels of analytic performance and ensuring that these levels are -- 2 of 3 -- maintained throughout the entire testing process for two of two lots of controls reviewed between 2017 and 2018. The findings included: 1. Based on review of the Hycor Specific and Total IgE Controls (Ref 71207), the instructions for use states the following under EXPECTED VALUES: "The control ranges listed have been established by Hycor Biomedical. Because of differences in reagent lots and individual laboratory equipment, it is recommended that these values be used as guidelines to aid in establishing a range with accurately reflects user performance." 2. Based on review of the laboratory's procedure titled "Technical Procedure for Total IgE Testing EIA", approved by the laboratory director on 1/9/17, under QUALITY CONTROL, states the following: "Mean values with acceptable ranges are established internally and are used to monitor assay performance. The Levy-Jennings graphs, available within each of the 4 Hytec 288 analyzers, will be printed on a monthly basis and reviewed for shifts and trends, accuracy, and precision. Ranges for each new lot of liquid controls are generally determined by calculating the mean and standard deviation from 20 replicate runs performed over at least 3 days if possible. The target is set at plus or minus two standard deviations from the mean unless specifically stated otherwise within the assays procedure. The new lab mean must fall within the manufacturer's stated range to be valid." 3. The Technical Consultant failed to ensure that the laboratory established a plus or minus two standard deviation acceptability criteria as required by the laboratory's procedure. 4. The Technical Consultant failed to ensure that the laboratory did not include extreme outliers in the establishment of acceptability ranges for two of two lots of control materials. 5. The Technical Consultant failed to ensure the laboratory printed Levy-Jennings graphs monthly to be review for shifts and trends, accuracy, and precision, as required by the laboratory's procedure. The laboratory had printed bar graphs that do not include accuracy or precision statistics such as mean, standard deviation, or coefficient of variation. The bar graphs do not display the relationship between the daily values and accuracy or precision statistics such as mean, standard deviation, or coefficient of variation. Refer to D5469. -- 3 of 3 --